Most Recent Clinical Trial Update
Aug 2023
Following the Phase Ia study, we explored how the engrafted cells might impact their response to an analytic treatment interruption.
To do so, we designed a follow-on study with six participants from the Phase Ia trial. This new study featured an analytical treatment interruption (ATI) where we took the participants off of their antiretroviral therapy (ART) and evaluated their immune response to the virus.
You can learn more about the analytical treatment interruption (ATI) here.
HIV Clinical Trial Timeline
Aug 2020
FDA clears AGT to begin clinical trial
Nov 2020
First trial participant enrolled.
May 2021
First participant infused with AGT103-T.
Dec 2021
Clinical trials demonstrated blood markers of efficacy.
July 2022
Began withdrawing participants from their antiretroviral drug.
Nov 2022
Completed Phase 1a human clinical trial with no serious adverse events.
Aug 2023
Analytical treatment interruption (ATI) Study.
2024
Initiates planning for Phase 1b human clinical trial.
HIV Cure Countdown
American Gene Technologies is making great progress in our ongoing HIV clinical trial. Here is a countdown from when we first started this journey in 2019 to 2024. We highlight key milestones we’ve achieved so far, as well as future developments we are working toward — all in an effort to potentially cure HIV.
Completed Milestones
10
FDA Allows Clinical Trial
August 2020
After promising pre-clinical studies, the Phase 1a trial for AGT103-T was 'greenlit' for a Phase 1 human trial.
It’s official, the Phase 1 trial is now open and seeking trial participants!
09
Phase 1a Began
October 2020
American Gene™ Phase 1a trial officially opened and started seeking trial participants.
08
First Participant Enrolled
October 2020
The first trial participant was enrolled in the Phase 1a trial of AGT103-T.
07
First Product Passes Release Testing
April 2021
After Phase 1a began and the trial participants were enrolled, American Gene manufactured AGT103-T and passed an extensive panel of safety testing.
06
First Patient Infused
May 2021
The very first trial participant received an infusion of AGT103-T.
05
Three Patients with No Serious Adverse Events; DSMB Accelerates Trial
November 2021
After no serious adverse events were recorded from the first 3 patients, the DSMB voted unanimously to continue the program at a faster pace. The 4th and 5th patient were treated in November 2021.
04
Three Patients with No Serious Adverse Events; DSMB Accelerates Trial
February 2022
The AGT103-T gene and cell therapy was tested on participants, giving us a sneak peek at efficacy data that normally occurs in Phase 2. The initial data showed blood markers of efficacy in all five clinical trial participants.
Upcoming Milestones
03
First Human Efficacy
Upcoming
Given that participants in the study are living with HIV and have been given a therapeutic dose of the experimental drug, American Gene may actually see some patients go into durable remission and be able to go off of their ARTs.
02
Phase 2 Approved
Upcoming
A successful Phase 1a will lead to a Phase 2 study, which could be pivotal. Gene and cell therapies frequently get limited license in a Phase 2 study.
01
Phase 2 Completed
Upcoming
Successful completion of a Phase 2 study may give us the ability to apply for a limited license, sometimes referred to as a BLA. The FDA will consider whether sufficient safety has been shown, and if efficacy is attractive.
00
Biologics License Agreement (BLA)
Upcoming
We’re hopeful that our clinical successes will merit a license. Provided the successful clinical studies, the BLA will allow American Gene Technologies to offer the therapy commercially.
Have Questions? Get Answers.
Visit our knowledge base for answers to FAQs about American Gene Technologies' HIV cure program and Phase 1a clinical trial.
How Does AGT103-T Work?
Watch our CEO break down American Gene Technologies' gene and cell therapy strategy for curing HIV.
Solving The Riddle, A Consequential Approach
As we work toward the next milestone in the HIV Cure Program, learn more about the history of HIV that has been developing over the last 40 years